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Nov 15, 2013 9:00am EST
two, one last week and one on wednesday. on wednesday we approved a truck for mantle cell lymphoma which is a rare kind of immune system or blood tumor, all right? and so we feel this program has been fair hi successful so far in -- fairly successful so far in bringing greater attention to drugs that are potential game changers for people with serious diseases. >> all right, thank you. dr. shuren, the industry and the fda agreed to have an independent, two-phase assessment and program evaluation to object ily assess the fda's premarket review process. can you explain how fda was involved in setting the parameters of this assessment? >> certainly. we put out calls for independent contractors -- [inaudible] and that was a -- my acoldies. we had put out a call to have an independent contractor perform the assessment, and booz allen hamilton is that contractor. we worked on a draft statement of work which we put out to the public for comment. we had discussions with industry on what should go into that statement of work, and then finally, we've been overseeing the process for the contr
Search Results 0 to 0 of about 1